NCT07360288

Brief Summary

This Phase II, multi-center, single-arm, open-label study evaluates the efficacy and safety of TC011, a CD19-targeted CAR-T cell therapy, in adult patients with relapsed or refractory follicular lymphoma (Grade 1, 2, or 3a). The primary endpoint is objective response rate (ORR) assessed by independent review using the Lugano 2014 classification.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
47mo left

Started Mar 2026

Typical duration for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Mar 2026Feb 2030

First Submitted

Initial submission to the registry

January 14, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

Expected
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2030

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

2.3 years

First QC Date

January 14, 2026

Last Update Submit

January 14, 2026

Conditions

Follicular Lymphoma (FL)

Keywords

Follicular LymphomaCAR-TCD19Adoptive Cell TherapyImmunotherapy

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate (ORR)

    Proportion of patients achieving CR or PR per 2014 Lugano classification by independent review

    Up to 96 weeks

Secondary Outcomes (8)

  • Complete Response Rate (CRR)

    Up to 96 weeks

  • Disease Control Rate (DCR)

    Up to 96 weeks

  • Stable Disease Rate (SDR)

    Up to 96 weeks

  • Duration of Response (DOR)

    Up to 96 weeks

  • Time to Response (TTR)

    Up to 96 weeks

  • +3 more secondary outcomes

Study Arms (1)

TC011 single-arm

EXPERIMENTAL

Single-arm, open-label study receiving TC011 infusion.

Biological: TC011 single-arm

Interventions

TC011 single-armBIOLOGICAL

CD19-targeted chimeric antigen receptor T-cell therapy

TC011 single-arm

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to provide written informed consent.
  • Age ≥19 years at the time of screening.
  • Histologically confirmed follicular lymphoma Grade 1, 2, or 3a according to WHO 2017 classification.
  • Relapsed or refractory disease after at least two prior systemic therapies including rituximab.
  • ECOG performance status ≤2.
  • Life expectancy ≥12 weeks.
  • At least one measurable lesion (long diameter ≥1.5 cm).
  • Adequate hepatic, renal, hematologic, pulmonary, and cardiac function.
  • Eligible for leukapheresis and successful manufacture of TC011.
  • Agreement to use effective contraception for at least 6 months after TC011 infusion.

You may not qualify if:

  • Histologic transformation to diffuse large B-cell lymphoma or follicular lymphoma Grade 3b.
  • Unresolved ≥Grade 2 toxicity from prior anticancer therapy (excluding hematologic abnormalities).
  • Active or prior malignancy within 2 years, except adequately treated non-melanoma skin cancer or carcinoma in situ.
  • Clinically significant cardiovascular disease within 6 months prior to screening.
  • Active central nervous system involvement by lymphoma.
  • Active uncontrolled infection, including HBV, HCV, HIV, or syphilis (protocol-defined exceptions apply).
  • Active autoimmune or inflammatory neurologic disease.
  • Rapidly progressive disease requiring urgent therapy.
  • Prior treatment with anti-CD19 therapy, adoptive T-cell therapy, gene therapy, or allogeneic stem cell transplantation.
  • Major surgery within 4 weeks prior to screening.
  • Use of investigational agents within 4 weeks prior to screening.
  • Known hypersensitivity to components of TC011.
  • Pregnant or breastfeeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Won Seok Kim, MD, PhD

    Samsung Medical Center, Department of Hematology-Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2026

First Posted

January 22, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

February 28, 2030

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share